Carbon debuts dental technology platform
Carbon’s L1 3D printer (Image from Carbon)
3D printing company Carbon unveiled an integrated technology platform for the dental market this week at the International Dental Show in Cologne, Germany.
The platform combines software, hardware and materials in an end-to-end solution designed to meet the needs of dental and orthodontic labs and enable them to scale quickly and economically, according to the Redwood City, Calif. company. Carbon also debuted its new M2d printer for mid-sized dental and orthodontic labs with lower volume needs, as well as its L1 Production Solution for high-volume production of clear aligner mo...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Dental Featured News Well Carbon Dentsply Sirona dreve internationaldentalshow keystoneindustries Source Type: news
PolarityTE reveals SEC investigation
PolarityTE (NSDQ:PTE) this week revealed that it is the target of an SEC investigation into possible violations of federal securities laws.
The Salt Lake City, Utah-based company said that it received a copy of a formal order of investigation from the SEC on March 4, exploring possible violations of fraud and price manipulations, according to an SEC filing.
Read the whole story on our sister site, Drug Delivery Business News
The post PolarityTE reveals SEC investigation appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Legal News Regenerative Medicine polarityte Source Type: news
Nyxoah sleep apnea neuro-stim therapy gains CE Mark
Nyxoah said it has won the CE Mark for its novel hypoglossal nerve stimulation therapy for treating obstructive sleep apnea (OSA).
The Genio system is a battery-free, leadless and minimally invasive neurostimulator designed to deliver bilateral hypoglossal nerve stimulation for moderate to severe obstructive sleep apnea patients who have failed conventional continuous positive airway pressure (CPAP) therapy.
Get the full story on our sister site, Medical Design & Outsourcing.
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Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Source Type: news
OptiScan raises $20m for bedside glucose monitoring system
OptiScan Biomedical said today that it closed a $20 million Series E round to support the commercialization of its continuous monitoring system, the OptiScanner 5000, in the U.S.
The company’s device is an automated bedside blood glucose monitor designed for use in the intensive care unit. The system can measure glucose values from a micro-sample of blood without the need for calibration, according to OptiScan.
Get the full story at our sister site, Drug Delivery Business News.
The post OptiScan raises $20m for bedside glucose monitoring system appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Diabetes Featured Funding Roundup Hospital Care OptiScan Source Type: news
Ex-NuVasive CEO Lucier to head new M & A firm Corza Health
Ex-NuVasive CEO Gregory Lucier will lead new M&A-focused company Corza Health.
Recently departed NuVasive (NSDQ:NUVA) CEO Gregory Lucier will lead a new company formed to acquire medtech and life sciences firms and assets.
Lucier, 54, is partnering with Chicago-based private equity firm GTCR to form the new company, Corza Health, in San Diego. GTCR holds stakes in Regatta Medical, which owns laser micro manufacturer Resonetics and Sotera Health along with life sciences, technology, and financial and business services companies.
Get the full story on our sister site, Medical Design & Outsourcing.
The post Ex...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Featured Mergers & Acquisitions News Well Orthopedics Robotics bestbuy corzahealth greatcall gtcr Life Technologies Corp. Nuvasive Thermo Fisher Scientific Source Type: news
Ex-NuVasive CEO Lucier to head new M & A firm
Ex-NuVasive CEO Gregory Lucier will lead new M&A-focused company Corza Health.
Recently departed NuVasive (NSDQ:NUVA) CEO Gregory Lucier will lead a new company formed to acquire medtech and life sciences firms and assets.
Lucier, 54, is partnering with Chicago-based private equity firm GTCR to form the new company, Corza Health, in San Diego. GTCR holds stakes in Regatta Medical, which owns laser micro manufacturer Resonetics and Sotera Health along with life sciences, technology, and financial and business services companies.
Get the full story on our sister site, Medical Design & Outsourcing.
The post Ex...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Featured Mergers & Acquisitions News Well Orthopedics Robotics bestbuy corzahealth greatcall gtcr Life Technologies Corp. Nuvasive Thermo Fisher Scientific Source Type: news
Boston VC shop Flagship Pioneering raises $824m with 8th fund
Life-sciences focused venture capital group Flagship Pioneering said today that it raised $824 million for its new Special Opportunities Fund II, which aims to support companies created by its Flagship Labs unit.
The funds join an existing capital pool of more than $700 million Flagship said it raised between late 2017 and 2018 to finance its in-house plays.
Investors in the new Special Opportunities Fund II include long-time limited partners, new institutional investors and family offices and follows the $285 million Special Opportunities Fund I which closed in 2016.
Flagship said that it has launched more than 75 venture...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Source Type: news
Syneron Candela, InMode settle patent suits
Syneron Candela (NSDQ:ELOS) said today it inked a settlement deal with InMode Aesthetic Solutions to end a patent dispute between the companies.
Through the settlement deal, Wayland, Mass.-based Syneron Candela said that it offered InMode a sublicense to continue to market its bi-polar fractional radiofrequency product line. The companies did not release terms of the settlement deal.
Each party in the suit will cover their own costs, attorney’s fees and expenses, according to court documents from the U.S. District Court for the District of Massachusetts, while the charges were dismissed with prejudice.
“Candela is...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Fink Densford Tags: Legal News Patent Infringement Syneron Medical Ltd. Source Type: news
Siemens wins FDA nod for Mobilett Elara Max mobile X-ray
Siemens (NYSE:SI) Healthineers said today that it won FDA 510(k) clearance for its Mobilett Elara Max mobile X-ray system.
The Erlangen, Germany-based company touted that the newly cleared system features improved IT security and secure system integration to allow access of patient data at any time.
Siemens Healthineers also said that the system features antibacterial coating and an improved ergonomic design for better maneuverability.
“Siemens Healthineers is pleased to offer the Mobilett Elara Max, a mobile X-ray system with advanced cybersecurity features that provide state-of-the-art patient data protection. Th...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance Siemens Healthineers Source Type: news
Brainlab acquires Medineering ’ s robotics platform
Brainlab said today that it acquired Medineering and its line of robot-assisted surgery devices for an undisclosed amount.
Brainlab, which earlier this month dealt its orthopedic joint reconstruction assets to Smith & Nephew (NYSE:SNN), is already an investor and markets the Medineering robot-assisted surgical arm under the Cirq brand. The Munich-based company said it plans to fold the Medineering tech into its open-architecture surgery offering.
“Medineering introduced a fresh new approach to surgical robotics when we entered into our partnership less than three years ago,” pesident & CEO Stefan Vilsme...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Mergers & Acquisitions Robotics Wall Street Beat Brainlab Medineering Source Type: news
FDA warns Integra ’ s TEI Biosciences over quality, validation issues
The FDA recently revealed a warning letter it sent to Integra LifeSciences‘ (NSDQ:IART) TEI Biosciences over four noted violations it found during an inspection of TEI’s Boston-based facilities.
The federal watchdog said that it inspected the company’s facilities where it produces collagen-based medical devices, including its Xenform soft tissue repair matrix, from last October to November last year.
The recently released letter covers both the noted violations and a number of responses from the company it received from last November to February.
The FDA’s first noted violation was a failure properly validate m...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Integra LifeSciences TEI Biosciences Source Type: news
Nevro taps ex-Thoratec CEO Grossman | Personnel Moves, March 20, 2019
Nevro Corp. (NYSE:NVRO) said yesterday that it named former Thoratec CEO Keith Grossman to replace president & CEO Rami Elghandour after striking a deal with one of its investors, Broadfin Capital.
Grossman re-joined Thoratec after taking over at Conceptus in December 2011 and leading it to a $1.1 billion sale to Bayer in June 2013 (he’d been Thoratec’s CEO from 1996-2006). Grossman helmed Thoratec until St. Jude Medical (now Abbott) acquired it in October 2015 for $3.3 billion.
Nevro said the deal with Broadfin also involves the expansion of its board of directors with the addition of Warburg Pincus limited p...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Business/Financial News AdvaMed California Life Sciences Assn CardioMech Check-Cap electroCore LivaNova Nevro Corp. Personnel Moves renovia Synaptive Medical Tactile Systems Technology Source Type: news
Sage wins historic FDA nod for postpartum depression therapy
Sage Therapeutics (NSDQ:SAGE) this week won FDA approval for the first medicine indicated to treat postpartum depression.
The Cambridge, Mass.-based company’s injection therapy, Zulresso, is slated to be available in late June.
Postpartum depression is the most common medical complication of childbirth, according to Sage, and affects roughly one in nine women who have given birth in the U.S.
Get the full story at our sister site, Drug Delivery Business News.
The post Sage wins historic FDA nod for postpartum depression therapy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Drug-Device Combinations Featured Food & Drug Administration (FDA) Neurological Pharmaceuticals Wall Street Beat sagetherapeutics Source Type: news
FDA warns J & J, Sientra over lack of post-approval silicone gel breast implant studies
The FDA today released warning letters it sent to Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide and Sientra (NSDQ:SIEN) over failures to conduct appropriate post-approval studies to analyze the long-term safety and risks associated with their silicone gel-filled breast implants.
The federal watchdog said that every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies of the devices to maintain appropriate data on the long-term safety and potential risks associated with the devices that premarket trials cannot foresee.
In its letter to J&J’s Mentor,...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Women's Health johnsonandjohnson Mentor Worldwide Sientra Source Type: news
Baxter, Biom érieux ink acute kidney injury biomarker dev deal
Baxter (NYSE:BAX) said today that it inked a partnership deal with Biomérieux looking to develop biomarkers to identify acute kidney injury.
The partnership was announced at the International Symposium on Intensive Care and Emergency Medicine, Deerfield, Ill.-based Baxter said.
Both companies said they hope to develop the biomarkers to help rapidly identify and inform treatment of acute kidney injuries, which can lead to death if untreated.
“We’re committed to improving outcomes for critically ill patients across the continuum of care, which includes identifying opportunities to diagnose AKI earlier so a patient...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diagnostics Research & Development Baxter BioMerieux Inc. Source Type: news
